Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Postacute Sequelae of Sars-CoV-2
CompletedNot applicableNCT05200858
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of the pilot study is to examine acceptability and proof of concept effectiveness of a wireless TENS technology to address PASC associated FM. Sample size (n=30) is convenient and designed to explore acceptability and feasibility. Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize TENS low-dose devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 4 weeks. Then, the patients will come back after four weeks (4W). At this 4th week visit, both groups will be unblinded and the IG will keep their high-dose TENS device and the PG group will switch from a low-dose TENS to a high-dose TENS device. Both groups will continue to deliver 3-5 hour of stimulation daily, until their final 8th week follow up visit (8W). The primary outcome will be pain. Secondary outcomes include fatigue, limb strength and perfusion, gait assessment (cadence, stride time, double support), balance, pulse oximetry, and quality of life. The coordinator will utilize a weekly spreadsheet showing utilization (therapy sessions/day, logged in the Quell health Cloud) so compliance can be monitored and those that are not using the device can be encouraged.
Study details
- Official title
- Transcutaneous Electrical Nerve Stimulation For Lower Extremity In Patients With Neurogenic Pain - A Proof Of Concept Randomized Clinical Trial
- Conditions
- Postacute Sequelae of Sars-CoV-2
- Post-Acute COVID-19 Syndrome
- Widespread Chronic Pain
- Fatigue Syndrome, Chronic
- Gait, Unsteady
- Interventions
- Device: TENS - high-dose
- Device: TENS - low-dose
- Sponsor
- Baylor College of Medicine
- Collaborators
- NeuroMetrix, Inc.
- Start date
- 2022-03-01
- Primary completion
- 2023-10-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Previous COVID-19 infection * Persistent symptoms of pain, fatigue, weakness, or poor gait and balance that were not present before COVID-19 infection * Willing to attend clinic for assessments Exclusion Criteria: * Severe cognitive decline reduces their ability to interact with the TENS mobile app * Major visual or hearing weakness reduces the ability to interact with TENS mobile app * Unable to walk independently for a distance of 10 meter * Major foot problems such as active lower extremity wounds, major foot deformity (e.g., Charcot Foot), previous major amputations, and claudication * Demand-type cardiac pacemaker, implanted defibrillator, or other implanted electronic devices; and any conditions that may interfere with outcomes or increase the risk of the use TENS based on the judgement of clinicians
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05200858